Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia

NCT05464108 | Completed

• 1 other identifier: 2022SDU-QILU-111
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 1

Brief Summary

The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

Conditions

Intestinal Metaplasia of Gastric Mucosa; Artificial Intelligence; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score

  A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, \> 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.

  2 years

Secondary Outcomes (4)

• Accuracy of experienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score

  2 years

• Accuracy of inexperienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score

  2 years

• Inter-observer agreement among experienced endoscopists in identifying the EGGIM scores

  2 years

• Inter-observer agreement among inexperienced endoscopists in identifying the EGGIM scores

  2 years

Study Arms (1)

Gastric intestinal metaplasia observed by IEE

Get pictures from gastric antrum body and angle by image-enhanced endoscopy in order to calculate the EGGIM score.

Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists

Interventions

The diagnosis of Artificial Intelligence and endosopists DIAGNOSTIC_TEST

Endosopists and AI will assess the EGGIM score independently when the patients is eligible. In addition, they can not see the OLGIM score of the patients.

Gastric intestinal metaplasia observed by IEE

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

You may qualify if:

• patients aged 40-75 years who undergo the IEE examination

You may not qualify if:

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric
• disorders who cannot participate in gastroscopy
• patients with previous surgical procedures on the stomach
• patients with contraindications to biopsy
• patients who refuse to sign the informed consent form

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastrology, QiLu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

When a gastric mucosal lesion is found using IEE , endoscopist will take biopsy for histology examination. In addition, random biopsies to ensure at least four biopsies from the gastric antrum and body to cauculate the OLGIM

Study Officials

• yanqing Li, MD, PHD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 19, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)